• Alcyone’s ThecaFlex DRx™ System is an implantable medical device in development to enable routine subcutaneous administration of therapeutics to the cerebrospinal fluid
• First stage of the pivotal study expected to initiate in summer of 2023 for first 10 patients followed by enrollment of the remaining 80 patients in a second stage beginning in 2024
Alcyone Therapeutics Inc. (Alcyone), a biotechnology company pioneering next-generation precision genetic therapies and precision delivery solutions of therapies for complex neurological conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to initiate a pivotal trial of Alcyone’s ThecaFlex DRx System (ThecaFlex). The PIERRE pivotal study will evaluate the safety and performance of the ThecaFlex subcutaneous port and intrathecal catheter system for repeat intrathecal access, cerebrospinal fluid (CSF) aspiration, and delivery of SPINRAZA® (nusinersen) in spinal muscular atrophy (SMA) patients.
The PIERRE pivotal study (https://clinicaltrials.gov/ct2/show/NCT05866419) will enroll up to 90 patients and will be conducted in two stages. The first stage is expected to be initiated in the summer of 2023 in a limited number of sites in the U.S. and will consist of up to 10 patients enrolled, implanted, and followed for 30 days. The second stage will enroll an additional 80 patients in a broader number of sites across the U.S. and Europe and is expected to begin in 2024.
ThecaFlex has the potential to be the first implantable device designed to enable routine subcutaneous access for delivery of antisense oligonucleotide (ASO) therapies. ThecaFlex has received a CE Mark in Europe. In addition, it has also received Breakthrough Device Designation from the U.S. FDA.
About The ThecaFlex DRx™ System
The ThecaFlex DRx System (ThecaFlex), a technology within Alcyone’s Falcon™ Delivery Platform, is an implantable intrathecal (IT) catheter, catheter fixation device, and subcutaneous port system designed to provide access to the cerebrospinal fluid (CSF) for the infusion of therapies requiring repeat IT dosing. Lumbar puncture (LP), commonly known as a spinal tap, is the current standard of care approach to delivering therapeutics into the CSF. ThecaFlex is designed to be an alternative to LP, especially for people with challenging anatomy or for those who require multiple anaesthesia and radiation exposures for repeat LPs or for patients whom the treating physician determines implantation of ThecaFlex is otherwise in the patient’s best interests.